Q : What needs to be documented for daily equipment verification testing?

A: The job isn’t complete until the paperwork is completed! Documentation should include the date, specific equipment, test results and name of the person documenting the results.

Verifying cleaning equipment performance is part of the quality assurance program. Equipment verification testing documentation should include the instructions for use (IFU) and detergent IFU to demonstrate that the critical parameters for mechanical cleaning are synchronized; this information must be available for confirmation and reference. Daily cleaning verification records are usually part of the IFU from the manufacturer of the cleaning verification test. Note: Different types of cleaning verification tests are available, and the methods of testing vary, as do the interpretation of the results.

Q : How long should we keep sterilization records?

A : Sterilization record retention varies throughout the country; each healthcare facility is responsible for determining its record-retention policy in accordance with state and local regulations and legal

considerations. Typically, this is based upon the individual situation and each state’s statute of limitation for lawsuits. To help determine your healthcare facilities’ record retention time, it is best to check with your compliance officer. Sterilization records should be retained in accordance with the policy and procedure established by the individual healthcare facility. Sterilizer manufacturers generally recommend preventive maintenance and repair records be maintained for the life of the equipment.

4Breaking NewsYou Can Use: Device Linked to Deadly Heart Surgery Infections2

Editor’s Letter: Give the Gift of Professionalism 5

Advocacy Corner:Legislative Updates for Pennsylvania & Massachusetts 6

Quality in Focus:Take Stock of 2018’s Successes, Setbacks and Goals 3

Link of the Month: FDA Delays Direct Label UDI Requirements

D E C E M B E R 2 0 1 8

The Jan/Feb 2019 issue of PROCESS magazine (formerly Communiqué) will be hitting mailboxes soon! In addition to the Disaster Preparedness cover story, here are some of the many other articles and features you’ll find inside:• Uncovering Common Instrument and

Processing Myths

• A Primer on Professional Organization/Agency Acronyms

• Study Sheds Light on Damage to Delicate Eye Instruments

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Ask the EXPERT By Natalie Lind, CRCST, CHL, FCS, IAHCSMM Education Director

This issue finds you smack dab in the middle of holiday season and I hope it finds you happy, healthy and full of good cheer!

This time of year has always been my favorite, for many reasons. Personally, I love everything about it (aside from the pushy shopping crowds and the seemingly inevitable weight gain from endless encounters with decadent treats). The festive decorations, the solitary reflection while nestled next to a cozy fire, quality time with friends and family, and even days off spent wrapping gifts and cooking feasts for a small army all make me warm inside and wishing December lasted more than 31 days.

In the midst of this season, I try to carve out quality time for myself to reflect, recharge and regroup. The past two years, I set aside vacation days to reconnect with my hobbies (photography classes are on my to-do list this year), tackle some creative writing and set my goals for the months and years ahead. It’s all done under the “No pressure, all pleasure” mantra and I’ve found it’s one of the greatest gifts I can give myself. I also reserve some time for professional growth. This year, I joined my local chapter of the Society of Professional Journalists and attended other events to help me sharpen my knowledge and network with others in the profession.

If you haven’t yet joined your local IAHCSMM chapter or participated in regional or annual conferences, perhaps 2019 will be your year. If you’ve set your sights on becoming certified (or earning “Triple” or “Golden” certification status), but haven’t yet made the time, let this be your year to set the ball in motion and nurture that important goal to fruition. Similarly, if you’ve yearned to reach another rung on the career ladder or assume a leadership role, it’s the perfect time to pursue that by seeking guidance from a mentor, committing to ongoing knowledge advancement and speaking with others in leadership positions to help you chart your own course for success.

At the same time, the holidays are a perfect opportunity to share our gratitude with our peers and colleagues and offer assistance whenever possible. Showing appreciation for a job well done and carving out some time during our own busy days to lend a hand and learn more about other departments’ needs and challenges are some of the greatest gifts you can give your healthcare customers, departmental teammates and patients. Even better, they are the gifts that keep giving.

I wish you a wonderful and memorable holiday season filled with happiness and good health, and a New Year filled with promise, enthusiasm and continued success! Thank you for the exceptional job you do each and every day in the name of quality, professionalism and patient safety!

LETTER from theEDITOR

Julie Williamson, Editor

The Best Gifts Are Wrapped in Professionalism

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“You don’t always know what’s coming, so you need to be able to pivot at a moment’s notice. That flexibility and ability to completely change directions according to the situation is very important.”

— Jo Wood, CRCST, CIS, Sterile Processing Training & Compliance Manager at Boston’s Massachusetts General Hospital

WORTH REPEATING

FDA Pushes Back Direct Label UDI RequirementsThe US Food and Drug Administration (FDA) is giving medical device manufacturers additional time to adopt unique device identification (UDI), specifically as it relates to direct mark requirements, in which a UDI is placed directly on a reusable device that is reprocessed between uses.

As described in the immediately-in-effect guidance document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking, the FDA will delay enforcement of direct mark compliance dates for Class I and unclassified devices (other than life-supporting or life-sustaining devices) until Sept. 24, 2022. After that date, the FDA wrote that it will not enforce UDI direct mark requirements if those devices are non-sterile, were manufactured and labeled prior to Sept. 24, 2022, and remain in inventory if the device’s UDI can be derived from other information that’s directly marked on the device.

In addition, the FDA has added a one-year grace period for medical devices that require a direct mark, are not implantable or life-supporting or life-sustaining and were manufactured and labeled prior to their label compliance date; however, devices manufactured after their label compliance date but before their direct mark compliance date must still meet their previous deadlines.

“This policy allows some realization of the benefits of UDI to patient safety for inventory devices that do not bear a UDI,” the FDA wrote, adding that the lower burden of the approach outlined in the guidance also reduces the risk that industry will choose to avoid the cost of remediation by discarding inventory, potentially creating device shortages and negatively impacting patients and providers. “Weighing the benefits and risks, we conclude that this compliance policy for certain inventory devices appropriately serves the public health.”

The FDA’s UDI rule was developed to better track medical devices throughout their life cycle using identification numbers (usually on the device’s label) and that are tracked in an online database. The published final rule in 2013 established the UDI system with an expected seven-year phase-in period based on a device’s classification; however, manufacturers reported that they were struggling to meet UDI requirements in 2016, which prompted the FDA to provide additional guidance on how the required information should be ordered. In January 2018, the FDA delayed enforcement of UDI compliance deadlines for some lower-risk devices.

The FDA identified “complex policy and technical issues that require resolution,” and the agency is currently focused on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before UDI-implementation issues for lower-risk devices.

While the current FDA guidance goes into effect immediately, public comments can still be submitted online at www.regulations.gov.

LINK OF THE MONTH

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B R E A K I N G N E W S

Device Linked to Deadly Heart Surgery Infections

More than 500,000 patients could have been exposed to bacteria that can cause serious illness or death. That’s the estimated number of patients who had open-chest surgery involving potentially contaminated equipment in the past several years. The bacteria are a type of nontuberculous mycobacteria (NTM). Although infections are rare, experts are worried because patients may not develop symptoms or signs of infection for months, so diagnosis may be missed or delayed.

The device is a heater-cooler unit, which helps keep a patient’s circulating blood at a specific temperature during operations. It’s used in an estimated 250,000 surgeries in the US every year, including cardiac bypass, valve replacement and liver transplants. About 60% of these procedures use the German-made model that has been linked to the infections, the Stöckert 3T heater-cooler, made by LivaNova PLC, formerly Sorin Group Deutschland GmbH. Researchers have found that fans on these units may blow bacteria from inside the machine into the Operating Room. If the bacteria land on a heart valve that is about to be implanted or a surgical wound, it could cause an infection.

The CDC is advising hospitals to notify patients who had open-chest surgery involving these devices going back to Jan. 1, 2012. There is new information that indicates these devices were probably contaminated during manufacturing. n

Swab from Smartphone Surface Offers Insight into Person’s Lifestyle

The typical smartphone is so dirty that a sample swab from the surface of a phone can accurately predict a person’s lifestyle choices, all the way down to how much beer they drink, a new study suggests. The study, conducted by researchers at the University of California at San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences, uses chemical analysis from molecules lingering on phones to determine basic lifestyle choices of the owner. Personal routine clues such as diet, cosmetic or makeup use, clothing and medication could be gleaned from the wide-reaching analysis, as well as environmental clues, such as ocean and sunscreen molecules, that could point toward locations where the owner recently visited.

The method draws on an understanding that the outermost layer of human skin carries chemical components drastically affected by the body’s inner chemistry and external, environmental factors. Researchers were able to capture the skin molecules present on these personal items and match them to a vast array of environmental and biological factors, quickly processing and cross checking databases using a supercomputer. Some of the molecules found on phone surfaces had lingered for extended periods of time. Researchers found traces of a mosquito repellent chemical on one participant’s phone, even though that person had applied the repellent nearly five months before the study.

Pieter Dorrestein and Amina Bouslimani, co-authors of the study, decided to use phones to collect samples because of their widespread use. They believe the applications of this type of broad chemical analysis are vast and cited possible medical applications that monitor the effect of medication on a patient. The effects of using cosmetics and skin-care products can also be monitored. They also mentioned potential law enforcement uses, where officials could analyze samples from phones, car keys, handbags or other personal items left at a crime scene to determine the profile of a suspect. n

Y O U C A N U S E

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REGISTRATION NOWOPEN

2019 ANNUAL CONFERENCE

& EXPO

JOIN IAHCSMM

ANAHEIM, CA APRIL 28 - MAY 1

EARLY BIRD PRICING THROUGH

2018

IAHCSMM Government Affairs Director, Josephine Colacci, Esq.

Coalition Gets Substitute Language Adopted for Legislation Aimed at Restricting Occupational Licensing & CertificationAs I stated in the October issue of Central Source, IAHCSMM joined the Professional Certification Coalition (PCC). This coalition consists of 100 non-profit organizations that are either membership organizations or certifying bodies. The PCC “will address efforts to enact legislation that would undermine the recognition of certifications developed or offered by private certification organizations.”

In 2018, states introduced legislation that would restrict occupational licensing and certification. Ohio held a committee hearing on an occupational licensing reform bill in November. The Coalition was successful in having substitute language adopted.

First, the substitute bill fixes a provision that would have called on the state government to offer a governmental certification program under certain circumstances. This would have set up the state as a competitor to voluntary certification programs. The PCC negotiated new language, which has been included in the substitute bill, that would allow for private voluntary certifications.

Second, the substitute bill now adds a provision to permit licensure boards to require private certifications as a condition of licensure. The PCC was concerned about the evidentiary presumptions the bill otherwise would pose to recognition of certification in licensure laws. The Federalism and Interstate Relations Committee will hold another hearing on the bill on December 5, 2018, during which it will adopt the bill.

Q: What is the status of our pending legislation in Pennsylvania and Massachusetts?A: Our Pennsylvania legislation will have to be reintroduced in January 2019. We are morehopeful than we have been in the past that our bill will have a committee hearing in early 2019.

Our Massachusetts bill is still making its way through the process. The legislature does not formally adjourn until the first couple days in January 2019. Massachusetts members, keep an eye on your email as you may see action alerts in your inbox. Please respond to help us get this legislation completed!

A D V O C A C Y

CORNERBy Josephine Colacci, Esq., IAHCSMM Government Affairs Director

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Q U A L I T Y I N F C U S

Time to Take Stock of the Year’s Successes, Roadblocks and Goals

T he end of the year marks a threshold and invites a pause for reflection, both personally and professionally. What follows are some questions to help Central Service/Sterile Processing (CS/SP) professionals navigate this important review process (in addition to the

organizational metrics that will also need to be reviewed). CS/SP professionals will also likely be asked to set new objectives for the coming year; this article will highlight some best practices for that — and pitfalls to avoid.

Questions for End-of-Year Review

What went well?Review the last 12 months and think about all the things that went well. It is natural and all too easy to focus on the negative. Starting out with some positive reinforcement will make addressing some of the negative a little easier.

Who needs to be acknowledged?Along with focusing on the negative, forgetting to thank those around us for all they do throughout the year is all too easy, as well. Think about the things that went well and the people who played a part in that. Let them know you appreciate their important role in those successes.

What’s not working well?Admittedly, delving into this question can be a bit unpleasant, but it’s important to take time to fully revisit and evaluate past mistakes or obstacles. We learn more from failure and difficulty than we do from success and ease — and glossing over our challenges can easily lead to stagnation. Try to approach this as objectively as possible. It’s not necessary to assign a cause or blame; instead, just acknowledge what isn’t working. That is a powerful first step that will help lead to correction.

With 2018 coming to a close, it is important to start looking forward again. Compiling a list of “What’s not working well” is an excellent place to start when considering goals for the new year. The new year is an opportunity to refocus and realign on the important components in our departments. While there will always be core tenants to the job (e.g., sterility and function), other areas of focus will come and go. CS/SP professionals have likely heard of the goal-setting process and may even use it at their organizations [at General Electric (GE), these are called SMART goals, which stands for Specific, Measurable, Achievable, Realistic and Timeline]. Breaking your goals into these SMART components can be the difference between hoping something happens and finding a way to make it happen. Still, merely focusing on these goals may be insufficient because it is possible to follow the process without focusing on critical areas of success. Because of this, GE added stretch goals that identify areas that were both challenging and important. The key to a stretch goal is for it to be difficult, but not so far out of reach that it crushes morale.

Common Pitfalls to Avoid

Be careful what you measure.

Tell me how you measure me, and I will tell you how I behave. — Eliyahu Goldratt

It can be as much art as it is science when selecting metrics to associate with objectives for the year. A personally favorite story that highlights how this can go badly comes from the world of sports. Vasili Alexeyev, a Russian super-heavyweight weight lifter, was offered an incentive for every world record he broke. The result of this contingent was that he kept breaking world records by only a gram

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or two at a time, often his own world records, to maximize his reward payout. It is easy to imagine how measurement in one area can drive poor results in another.

Avoid measuring the wrong thingsDysfunctional measurement is often caused by organizations doing the wrong things for the right reasons. To reduce customer wait time, an insurance company (known for its customer focus) invested in a device to measure average customer wait time for each call center team. The company mounted a digital scoreboard above the office cubicles for all to see; this caused employees to get their customers off the phone quickly, even if their issues had not been completely resolved, just so the customers in the queue wouldn’t have to wait. It also compromised customer service behaviors (like empathy for a customer who had recently experienced a death in the family). To the CEO’s credit, when he realized the problem, he immediately acknowledged it and replaced the “wait time” measure with one that measured the percentage of customers who completed their business on the first call, with no need for follow-up.

Discuss and share goals and metrics before finalizingThe goal-setting process has a powerful effect on motivation. I encourage all in leadership positions to involve their team, peers and customers in their process. Consider this example of measurement gone wrong: An automobile industry executive explained that to receive his quarterly bonuses “all that mattered was meeting production quotas and getting the cars out of the factory.” What happened after that was somebody else’s problem. That is certainly not a good way to work.

It is easy to imagine the results if something like that were implemented between CS/SP and the Operating Room (OR). What objectives and metrics could be set that would support both OR and CS/SP goals? It is important to ask how those objectives align with the overall organizational goals and whether they align with the vision and values of the organization.

ConclusionPerforming an end-of-year review to understand how we, our team and organization performed over the past year is essential for ensuring we stay on the correct course and it can provide guidance on where we want to go in the future. We must continue to question the processes and metrics around us, and we must realize that just because something used to be a valuable measure does not always mean it still is.

Nicholas Schmitz is President of Schmitz Consulting LLC. He holds two Master’s degrees in organization development and change management, and project management, and is a certified Project Management Professional and Lean Six Sigma Black Belt.